Novel Application of Cryoneurolysis for Neuromuscular Relaxation Prior to Abdominal Wall Reconstruction
University of South Florida
Summary
The goal of this clinical trial is to learn if cryoneurolysis, a targeted cold therapy applied to nerve branches, can relax the muscles of the abdomen to facilitate surgical repair of abdominal wall hernias. The main questions it aims to answer are: * Does cryoneurolysis result in changes to the length of the abdominal oblique muscles and hernia size? * Are there any side effects with the procedure? * What are the rates of complete hernia closure and component separation at the time of hernia repair? Participants will * Undergo cryoneurolysis procedure between two to six weeks prior to scheduled hernia repair * Complete a telephone visit 24-48 hours after the procedure to review any side effects * Undergo repeat computed tomography (CT) scan one to two weeks after the procedure to detect changes to the abdominal muscles and hernia size * Undergo routine postoperative clinic visits including 30 days after hernia repair surgery
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Planning to undergo ventral hernia repair * CT scan available within the past 6 months, demonstrating ventral hernia transverse defect size \>8 centimeters (cm) or loss of domain (defined as Tanaka index \[hernia sac volume:abdominal cavity volume\] of 0.25 or greater) Exclusion Criteria: * Use of any anticoagulant or antiplatelet medications is an absolute exclusion criterion. No holding protocol exists for these medications, and patients currently taking any of the following agents are ineligible regardless of the ability to temporarily discontinue: aspirin (any dose…
Interventions
- DeviceCryoneurolysis
Targeted cold therapy to the motor nerve branches of the abdominal oblique muscles to temporarily relax the muscles before hernia repair.
Location
- University of South FloridaTampa, Florida